STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 452
- 试验地点
- 2
- 主要终点
- Mean change in step count per day
研究概览
简要总结
The aim of this study is to investigate whether a smartphone app can increase physical activity in patients with Parkinson's Disease in daily life for a long period of time (12 months).
详细描述
Rationale: Exercise affords health benefits for people with Parkinson's disease (PD), but implementing exercise in daily life remains challenging. Moreover, many training programs are not very scalable. The investigators take an important step forward by developing and studying an innovative and fully decentralized smartphone-based program to increase long-term physical activity in people with PD in daily life.
Objective
The aim of this study is to investigate whether a smartphone app can increase physical activity in PD patients for a long period of time (12 months). The secondary aim is to test the potential group effect on physical fitness, motor- and non-motor symptoms. Thirdly, we aim to investigate whether there is a dose-response relationship between amount of physical activity and physical fitness, motor- and non-motor functioning.
Study design: Double-blind randomized controlled trial.
Study population: A total of 452 Dutch patients with PD who have no other medical conditions that markedly hamper mobility other than PD, no cognitive impairments that make it difficult to use a game on the smartphone and possess a suitable smartphone, will be recruited.
Intervention: Participants will be randomized to a group that will be motivated to increase their physical activity level to a small, medium, large or very large degree with respect to their own baseline level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic PD
- •Hoehn and Yahr 1-3
- •able to understand the Dutch language
- •able to walk independently
- •equal to or less than 120 minutes of sports/outdoor activities per day (question 5-28 LASA Physical Activity Questionnaire (LAPAQ))
- •less than 7,000 steps/day during 1-month baseline (week -4 until 0)
排除标准
- •weekly falls in the previous 3 months
- •medical conditions that hamper mobility other than PD
- •living in a nursing home
- •cognitive impairments that hamper use of the motivational app (subjective evaluation by the assessor)
- •not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 or higher or Android 4.1 or newer)
结局指标
主要结局
Mean change in step count per day
时间窗: Week -4 until 0 and week 49 until 52
Mean change in step count per day as measured continuously with the participant's smartphone from baseline (week -4 to 0) to follow-up (week 49-52). Higher scores indicate more physical activity (steps).
次要结局
- Change in physical fitness (6MWT)(Week 0 (baseline) and week 53 (follow-up))
- Change in motor- and non-motor aspects of daily living(Week 0 (baseline) and week 53 (follow-up))
- Change in physical fitness (VO2max)(Week 0 (baseline) and week 53 (follow-up))
- Change in Parkinson's Disease symptoms (MDS-UPDRS)(Week 0 (baseline) and week 53 (follow-up))
- Change in ambulatory capacity (MDS-UPDRS)(Week 0 (baseline) and week 53 (follow-up))
- Change in mobility (TUG)(Week 0 (baseline) and week 53 (follow-up))
- Change in balance (Mini-BestTest)(Week 0 (baseline) and week 53 (follow-up))
- Change in gait speed (10MWT)(Week 0 (baseline) and week 53 (follow-up))
- Change in fear of falling (FES-I)(Week 0 (baseline) and week 53 (follow-up))
- Number of falls and near-falls (monthly fall diary)(Every four weeks after start of the intervention (at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks).)
- Change in handgrip strength(Week 0 (baseline) and week 53 (follow-up))
- Change in self-reported physical activity level (LAPAQ)(Week -4 (screening), week 0 (baseline) and week 53 (follow-up))
- Change in cognition (MOCA)(Week 0 (baseline) and week 53 (follow-up))
- Change in depression and anxiety (HADS)(Week 0 (baseline) and week 53 (follow-up))
- Change in apathy (AES-12PD)(Week 0 (baseline) and week 53 (follow-up))
- Change in fatigue (FSS)(Week 0 (baseline) and week 53 (follow-up))
- Change in severity of sleep problems and daytime sleepiness (SCOPA-SLEEP)(Week 0 (baseline) and week 53 (follow-up))
- Change in autonomic dysfunction (SCOPA-AUT)(Week 0 (baseline) and week 53 (follow-up))
- Change in Health related quality of life (PDQ-39)(Week 0 (baseline) and week 53 (follow-up))
- Perceived effect of intervention (GPE)(At week 53 (follow-up))
- System Usability (SUS)(At week 53 (follow-up))
- Perceived physical ability (LIVAS)(Week 0 (baseline) and week 53 (follow-up))